Presentation on the importance of Patient Attitudinal Research before the study progresses too far. Ask yourself: Do you know how your Protocol tastes? If it doesn't taste great to a patient or caregiver, they will never finish the study, and you have no data.

1. Patient Attitudinal Research
Regarding Study Participation
What have we learned and
how can it help us enroll and
keep patients
John Needham
PatientQuest

2. Learning Objectives
• Assess aggregated results from recent patient
surveys:
– What do patients think about trials
– Where are they getting information about trials
– What are their perceived barriers to joining
– How has their disease affected their life and the
relationship with their family
– What are they expecting from the site in the way of
retention efforts
– How far are they willing to travel
• How these answers different outside the US
• How we use this insight to better approach patients

3. A Patient-Centered Mindset….
• Is more about how patients think or what
they feel or how they see themselves and
their disease rather than what they normally
do
• Especially important in high-involvement
decisions (e.g. finances, automotive, family
matters, health)
• Explores complex motivations and needs
• Predicts behavior

4. Maslow’s Hierarchy of Needs
Being Needs
Deficit Needs

5. Patient Attitudinal Research
Oncology
USA: Moffit, Sloan Kettering, Fox Chase
N= 200 participants
January 2011

6. Newly Diagnosed Oncology
Patients
• Most looking for “hope” and second opinion.
Majority are diagnosed and begin treatment
elsewhere; not treatment naive
• Do not know what a clinical trial is:
– It’s what they do after the regular drug doesn’t work
• Hope they are not offered one so they don’t have to
deal with those decisions
– I don’t want to be a guinea pig
• Would participate if MD suggested
– if the Dr. tells me to do it, I will

7. Currently Treated Patients
• Don’t understand purpose of trials
– “Trials are what they do when they don’t know what to
do with you? Standard treatment is best”
– “I thought that was for rare diseases? I have regular
old lung cancer.”
• Equate trials with experimentation
– “I don’t want anything that hasn’t been tested.”
– “Why should I waste the time I have left so somebody
can monkey around with a new idea?”

8. Patients who did not
participate in a Clinical Trial
• Being offered a trial means my condition is
hopeless
• “Thank goodness I didn’t get offered a trial,
that means there is still hope for me.”
• Skeptical of science and scientific procedures
• “Trials are for guinea pigs or the elderly who
don’t have much time left anyway”
• “I wouldn’t want to get a placebo and they do
that to you without you knowing that.”

9. Patient Attitudinal Research
Bipolar Depression
USA, Colombia, India, RSA, Czech Republic, Russia,
Ukraine
N= 320 participants
April 2011

10. Do you feel that your Doctor
understands your condition or Has the doctor ever used the
mood swings? term "bi-polar" or "manic
depression" to describe your
mood swings?
a. Not as
concerned as I
32% 34% would like
b. Yes
39%
a. Yes
c. No
b. No
61%
34%

11. Do you feel that you have received
enough information from your Doctor,
clinic, support group or the internet to
help you manage your mood swings?
Are you looking for new treatment
options or different medications
63% which may perform better than
your current prescription?
70%
60%
60%
50%
37%
40%
40%
30%
20%
10%
0%
a. Yes b. No a. Yes b. No

12. What might be a challenge for you when considering
participation in a study with 8 appointments scheduled
over 10 weeks?
36%
26%
12%
11%
10%
4%
a. My job b. School schedule c. Embarrassment d. Bad weather for e. Some days I can f. Pressure from
about my traveling to the not leave the my family or
condition doctor house, too friends about
depressed being in a research
study

13. Do you look for advice on your
mood swings on the internet?
Where would be a good place to put the
messages about our research study? (pick 2)
a. Yes b. No
21%
28% 18%
12%
11%
8%
6%
4% 4% 3% 3% 3% 3%
72% 2% 2%

14. CareforPE
Attitudinal Research Insights
420 responses in <1 week
10 countries OUS
10% enrollment after 90% of time
Agency never tested message

15. Untested Image: Effective?
Countries:
Austria
Belgium
France
Germany
Italy
NL
Spain
Sweden
UK
Bulgaria
Czech Rep
Hungary
Poland
Romania

16. Male Summary
• 78% experience with every partner
• Poland, Hungary responders youngest; Italy, US,
UK oldest
• 84% have never tried OTC products
• Emotions:
– Embarrassed
– Insecure
– Disappointed
– Anxious
– Frustrated
– Let down
– Angry

17. Female Summary
• Mixed results in comfort level talking about intimate
details during a trial question
– Yes UK, Italy, Poland
– No Germany, Netherlands, Hungary
• 72% do not help partner with PE
• Married 47%, living together 10%, not living together
but monogamous 37% (varies)
• Emotions: disappointed, depressed, irritated,
embarrassed, frustrated

18. Clarity Gained
• Opioid concern ~ 1/3 Yes vs. 2/3 No
• 2/3 of men feel they will not outgrow PE
• 2/3 seek info on the internet
• 10% of males tell friends; 40% of women do
• Italy, Hungary, Romania most hits: > 50 in 1 day
• Sweden, France, Czech Republic: single digits

19. Uncertainties
• Pharmacotherapy ~ 50/50
• 33% of males unwilling to speak with MD
• ~ 50% talk with partner; 28% partners try to help
• <10% have been in a trial
• Is this condition sufficiently urgent to join a study:
12% male and 23% female say PE strains their
relationship

20. Looking Forward
• Target: >40 & married
• First time help seeker, not too afraid to talk
• Need open minded female partner; more common
in major cities/ liberal minded
• Messages: help each other, increase positive
experience, decrease anxiety and sexual
frustration

21. Surprise! Failed Image: why?

22. PDNP Patient Survey Results
www.carefortinglingfeet.com
N=712

23. I would describe my pain as: (Check all that How would you describe your pain?
apply.)
27%
25%
a. Pins and needles
19%
10% b. 17%
24% Stabbing/shooting
23% c. Burning
11%
16%
d.
13% Aching/throbbing
14%
e. Numb
f. Sharp
a. Mild b. Comes and c. Sometimes d. Mostly bad e. Always bad
goes bad at night

24. What kind of doctor specialty do you consult for your pain?
5%
4% 13% a. Neurologist
3%
b. Pain physician
11% c. Endocrinologist
d. Diabetologist
44% e. General Medicine/Family
Practitioner
20%
f. Podiatrist
g. Other, please specify:

25. Do you feel that your Doctor understands your level of pain and how
it is affecting your quality of life?
54%
28%
18%
a. Not as much as I b. Yes c. No
would like

26. Do you feel that you have received enough information from your Doctor, clinic,
support group or the internet to help you manage your pain?
76%
24%
a. Yes b. No
Are you looking for new or different medications which may perform better than your
current prescription?
b. No
24%
a. Yes
76%

27. Would you consider joining a clinical study if the doctor conducting the
study was not your own doctor?
43%
37%
21%
a. Yes b. I would like to meet the c. No thanks
doctor before I decide

28. Where would be a good place to put the messages about our
research study? (pick 2)
19%
15% 16%
11%
10%
9%
6%
4%
3% 3%
2% 2%
1% 1%

29. Which image would be effective in getting your attention about a diabetic
neuropathy clinical trial?
33% 19% 20%
13% 11% 4%

30. USA PI PDNP Survey Results
www.pdnprecruitment.com

31. Which image would be effective in getting your attention about a diabetic
neuropathy clinical trial?
55%
32%
8%
5%
0% 0%
a. Nurse with Patient b. Barbed Wire - - - - c. Wringing Hands - - d. Flaming Hands & e. Foot Examination - f. Walking on Nails - -
--- --- --- Feet - --- ---

32. Patient Attitudinal Research
www.Tiredofcrohns.com
Completed in 6 days
Google Word Search
9,700 patients in Facebook Forum

33. How long did it take before you received the
accurate diagnosis you had Crohn's Disease
a. Less than 1 year 36%
b. 1 year 7%
c. 2 years 15%
d. 3 years 8%
e. More than 3 years 33%

34. Do you have concerns about
receiving infusion therapy (IV's)
40%
60%

35. Are you concerned or apprehensive
about needles and or injections?
30%
70%

36. If you currently take medication for Crohn's, how would you
feel about joining a study in which some of the participants
will receive a placebo?
32% a. No thanks
42%
b. I'd need to know my
chances of getting the
placebo
c. No big deal, I'm game
d. It depends on how good this
drug is
10%
16%

37. How willing would you be to undergo a colonoscopy
if it was required to join the study?
35%
40%
a. No thanks
b. No big deal, I'm game
c. It depends on how good this drug is
to see if it is worth it
25%

38. Would you be willing to join a clinical trial
if the physician is not your primary
doctor?
40%
a. Yes
b. No
60%

39. Where would be a good place to put messages
about our clinical trial (pick 2)?

40. Are Crohn’s Suffers Athletes?

41. PatientQuest
Chronic Pain
Patient Attitudinal Research
Google Word Search
Facebook ad words

42. What would be one word to describe how your
family feels about your Chronic Pain?
45
32
25
20
16
13
5
1
Worried, Annoyed, Angry, Indifferent; Empathetic, Helpless, Don't Sorry or Sad for me Gets in the way of They don't believe
Concerned Frustrated; Don't Unsympathetic Sympathetic know what to do our lives; Is hurting anything is wrong
Understand our relationship with me but I know
what I feel and it
isn't right and not
fair

43. Where would you most likely learn about
Chronic Pain Clinical Trials?
120
108
100
80
67
60
46
40
20
8
5 4
4 2
0 1
Facebook Local chapters Churches Newspaper Doctor's office Pharmacy Health food Internet sites Grocery store
networks of Chronic stores about Chronic pharmacy
Pain suppport Pain aisle
groups
Places to learn about Chronic Pain Clinical Trials

44. Which image represents how the chronic pain
makes you feel; which do you relate to?
32, 12% Chronic Pain 1
7, 3% 42, 16%
Chronic Pain 2
Crushed by Pain
Pain-Back
39, 15% 27, 11%
Pain-Barbed
Pain-Bolt
Pain-Cracks
7, 3% 47, 18%
15, 6% Pain-Masks
14,
Stamp Out
5%
29, 11% Weight of World

45. Select the Best Image

46. Which Images Resonate with Patients

47. Which Would You Select

48. What is Wrong with this
Diabetes Representation?

49. Which better represents OAB?

50. What image would get your attention so you
might consider learning more about a Crohn's
clinical study?

51. What image would get your attention so you
might consider learning more about a Crohn's
clinical study?
28% 16% 9.5% 8%

52. RA Survey Results-Images

53. Survey Results-Images

54. Survey Results-Images

55. Survey Results-Images
47/163 = 29%
19/163 = 12%
9/163 = 6%

56. Participants have expectations:
• What are the potential side effects
• Speak to the PI at every visit
• All travel / parking expenses provided
• A strong desire to meet other participants
• Create a supportive website just for the
study participants
• A mechanism to tell friends about the study
• Progress reports and lab results through
the trial on how they are responding to
treatment 56

57. Overarching Solutions
• Sponsors and CROs need a better
understanding of barriers to participation
(physical and emotional) and the Value
Proposition to overcome them
• Sites require continuous training in
effective listening, communication skills
and handling objections
• Caregivers should be viewed as integral
to the successful study completion

58. Question and Answers
• Content Discussion

59. What is Most Important to
Potential Participants
Similarity of Patient Responses
in Three Therapeutic Areas
PatientQuest Surveys
HIV >250 responses
OAB >400 responses
Psoriasis > 50 responses

60. Which would most likely affect your
decision to participate in a trial?
HIV Patients
140 100%
90%
Number of responses
117
120
80%
100 90 70%
80 60%
65
59 50%
55
60 50
40%
40 32 30%
20 20%
20
10%
0 0%
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2008 Clinical Research 60
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Educational Conference

61. Over Active Bladder Patients
Other
Driving distance to the study clinic
If this drug will do me any good
Duration or how long the study will last
Number of required study visits
Scheduling study appointments in my already busy schedule
Having to sit too long in the waiting room before being seen
Getting to an appointment
Birth control requirements
Taking the medication correctly
Possibility of receiving a placebo (sugar pill)
Possible side effects of the study medication
0 20 40 60 80 100 120 140 160
2008 Clinical Research 61
Educational Conference

62. Psoriasis Patients
Decision to participate in clinical trial
40
35
30
25
20
15
10
5
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63. Other than receiving a new medical treatment for
OAB, what else would interest you in joining and
remaining in a clinical research study?
US Results
Surgery or some other means of permanent cure
Prevention
Recipes that help promote a healthy bladder
Exercises to strengthen my bladder
Advice on how to get on with a normal active life
Empathic listening to how OAB disrupts my life
A trusted web site(s) for OAB information
On-going discussions with a urology specialist
2008 Clinical Research
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63
40 60 80 100 120 140
Educational Conference

64. Other than receiving a new medical treatment for
OAB, what else would interest you in joining and
remaining in a clinical research study?
EU Results
Recipes that help promote a healthier bladder
Exercises to strengthen my bladder
Advice on how to get on with a normal active life
Empathic listening to how OAB disrupts my life
A trusted web site(s) for OAB information
On going discussions with a urology specialist
2008 Clinical Research 64
0 5 10 15 20 25 30
Educational Conference

65. Which of the following would keep you interested
in participating in a study for a year or longer?
HIV 120 107 103 101 100%
Number of Responses
99 90%
100 86 83 80%
80 70%
60%
60 50%
40%
40 30%
20 20%
10%
0 0%
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66. Which would keep you interested in a
study for 3 months or longer?
USA OAB Patients
Other
Having access to my records the end of the
study
The hope of relief from my symptoms
"Appreciation items" when completing
milestones in the study (up to $50 total)
Monthly newsletter containing OAB related
information
Telephone reminder prior to my next
appointment
Appointment reminder notice by mail or email
"Thank you" letters after kept medical
appointments
Opportunity to meet other participants involved
in the trial, in a group setting
Free local or national support group
membership
0 20 40 60 80 100 120 140 160 180 200
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67. Which would keep you interested in a
study for 3 months or longer?
EU OAB Patients
Other
"Appreciation items" when completing milestones in the study
"Thank you" letters after kept medical appointments
Having access to my records and progress during the study
Vouchers for travel expenses and parking
Appointment reminder notice by mail or email
Telephone reminder prior to my next appointment
M onthly newsletter containing OAB related information
Opportunity to meet other participants involved in the trial, in a group setting
Free local or national support group membership
Regular access to a specialist doctor
The possibility of relief from my symptoms
0 10 20 30 40 50 60
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